AbbVie’s Imbruvica secures fourth breakthrough therapy designation from US FDA
pharmafile | July 1, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing | AbbVie, US FDA, drug trial, imbruvica
US pharma firm AbbVie (NYSE: ABBV) said the US Food and Drug Administration has granted Imbruvica a fourth breakthrough therapy designation (BTD) in a non-cancer indication.
The designation is for the treatment of chronic graft-versus-host-disease (cGVHD) after one or more lines of systemic therapy have failed. Imbruvica was also granted Orphan Drug Designation (ODD) for the indication.
Danelle James, head of oncology at Pharmacyclics, a unit of AbbVie, says: “This fourth breakthrough therapy designation from the FDA shows the promise of Imbruvica and its unique mechanism of action as a potential therapy beyond blood cancers, including chronic graft-versus-host-disease, a severe inflammatory condition with currently no approved therapies specifically for these patients. We are committed to continuing to evaluate the potential benefit ibrutinib may offer in treating blood cancers, solid tumors and other health conditions with unmet medical needs.”
The request for a BTD for ibrutinib in patients with cGVHD was based on preliminary clinical data from a Phase 1b/2 study evaluating the safety and efficacy of ibrutinib for the treatment of patients with steroid-dependent or refractory cGVHD.
In February 2013, the FDA granted breakthrough therapy to Imbruvica to treat relapsed or refractory mantle cell lymphoma and Waldenström’s macroglobulinemia. In April 2013, Imbruvica was awarded a third breakthrough theray designation for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma. Imbruvica is jointly developed and commercialized by Pharmacyclics, a unit of AbbVie and Janssen Biotech.
Anjali Shukla
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